FDA approves sale of Bose’s over-the-counter hearing aid

Posted:
Saturday, October 6, 2018 5:47 PM EDT

By Eric Brackett

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The Food and Drug Administration (FDA) has granted Bose approval to sell a hearing aid that can be used without the assistance of a medical professional. Hearing aids are nothing new, but this is the first one that will allow users to “fit, program, and control the hearing aid on their own, without assistance from a health care provider,’ according to an FDA press release.

The FDA’s report says that more than 37 million Americans suffer from hearing loss which can range in severity from “a little trouble” to “deaf.” One’s hearing can be impaired due to a number of factors including aging, exposure to extremely loud noises, or certain medical conditions. The Bose device is aimed to help those who suffer from mild to moderate hearing impairment.

One of the benefits of the Bose device is that it can be controlled and programmed through a mobile app, making it easier for users to make adjustments based on their needs. The device itself is an air conduction hearing aid which works by capturing sound waves and amplifying them through the use of microphones in order to produce louder sounds.

Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health, said that the approval of the Bose device should make it easier for patients with mild to moderate hearing issues to obtain the help they need.

“Today’s marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device,” said Eydelman. “The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care.”

While this device is the first of its kind to be approved for marketing, it won’t be the last. In 2017, Congress passed a law which cut back the need on consultation with a healthcare provider prior to using some hearing aids, which means we’ll likely see similar products on the market in the coming months and years. However, such devices will still need to comply with local and state laws, which might require a visit to a medical professional in order to obtain a hearing aid.

This is Bose’s first hearing aid aimed at this new standards, but it is not the first time they’ve made a product which can assist people with communication. In 2016, the company announced a set of earphones which could enhance conversations, making it easier to hear people in noisy places such as crowded bars or restaurants.